FDA Grants Mylan Tentative Approval for Generic Lamisil

The FDA has granted tentative approval to Mylan Pharmaceuticals' abbreviated new drug application for terbinafine hydrochloride tablets in a 250-mg dose.

The product is a generic version of Novartis Pharmaceuticals' Lamisil tablets, which are used to treat certain types of fungus. Lamisil generated net sales of $528 million in 2004, according to Novartis' latest earnings report.